Abstract: A vessel configured to contain a liquid is provided. The vessel includes a collapsible bad, a reusable support structure, a sensor, and a controller. The collapsible bag is operative to contain the liquid. The reusable support structure is operative to support the collapsible bag. The sensor is operative to measure a parameter within the collapsible bag. The controller is in electronic communication with the sensor and operative to introduce an antifoaming agent into the collapsible bag based at least in part on a signal received from the sensor.

Abstract: A probe assembly for inserting a probe into a flexible or semi-rigid object is provided. The probe assembly includes an aseptic connector for coupling to the object, a probe sheath that extends longitudinally from the aseptic connector, and an actuator for deploying the probe within the object. The probe sheath has a plurality of concentric sheath elements and an inner longitudinal volume that is configured to permit longitudinal movement of the probe within the probe sheath. The actuator moves the probe longitudinally within the probe sheath by telescoping a first sheath element of the plurality within another sheath element of the plurality such that the probe is moved to a position sufficient to measure at least one parameter within the object.

Abstract: Disclosed is a single-use bioreactor bag design providing substantially equivalent maximum shear rate at the impeller tip and average or bulk shear rate over a range of power per unit working volume and rpm needed for bioculture processing. The uniformity in shear profile of the bag design providing a unique advantage when used as a scale-down or scale-up platform. Also disclosed is a linearly scalable, single-use, bioreactor system for use in carrying out a scalable biomanufacturing process, the system comprising two single-use bioreactor bags of different volumes, wherein the ratio H/D of the height of the working volume H to the diameter D of the tank, or of the bag is equal to about 1.5, and the bulk shear in each of the bags is substantially constant. The disclosed small scale system models larger scale systems from both a shear/scalability/performance basis and also from a validation and regulatory basis.

Abstract: Systems for containing and manipulating fluids including systems and methods involving supported collapsible bags that may be used as reactors for performing chemical, biochemical and/or biological reactions contained therein are provided. Generally, a series of improvements and features for fluid containment systems such as gas delivery configurations, foam control systems and bag molding methods and articles for supported collapsible bag vessels and bioreactors are provided. For instance, in one aspect, fluids contained in a vessel can be sparged, e.g., such that a fluid is directed into a container of the vessel, and in some cases, the sparging can be controlled by rapidly activating or altering the degree of sparging as needed. Multiple spargers may be used in some cases. In another aspect, the vessel includes a seamless collapsible bag. In some cases, the collapsible bag may be injected, blown, or spin cast molded.

Abstract: A probe assembly for inserting a probe into a flexible or semi-rigid vessel or tubing having a distal aseptic connector for coupling to the vessel or tubing, the probe sheath comprising at least a portion that is rigid, the probe sheath extending longitudinally from the aseptic connector and having at least one inner longitudinal lumen configured to receive an elongate sensor or probe body and to permit longitudinal movement of the sensor/probe body within the probe sheath lumen, and an actuator for deploying a probe within the vessel or tubing by advancing the probe body through the aseptic connector to a position where the probe can measure at least one parameter within the vessel or tubing is disclosed herein.

Abstract: Embodiments of the present invention are directed to a customizable bio-manufacturing system which includes a manufacturing space having a first air handling system for providing supply air and a second air handling system for handling exhaust air, the supply air system being optionally provided with at least one of filtration, heating, cooling and or humidity control and a plurality of portable modules provided within the manufacturing space. At least one module having an interior capable of being interconnected with another module interior and each module's interior includes one or more components to perform at least one specific task of a biological, chemical, and/or pharmaceutical manufacturing process. At least one module includes an on-board environmental control system for controlling an environment within the module and a connection means for interconnecting the module interior with another module interior.

Abstract: Disclosed is a jacketed, tiered baffle, bioreactor tank comprising an outer cylindrical-shaped jacket and a cylindrical tank having an inner tank surface defining a chamber configured for supporting a flexible bag disposed within the chamber, and an outer tank surface having tiered baffles configured for routing a heat exchange fluid around the entirety of the outer tank surface, the cylindrical tank disposed axially within the outer cylindrical-shaped jacket. The outer cylindrical-shaped jacket is sealed to the cylindrical tank in a manner sufficient to prevent or minimize loss of the heat exchange fluid.

Abstract: Disclosed are magnetic agitation mixing systems for use with flexible container reaction vessels. In one aspect of the invention, the orientation of magnetic coupling between the impeller magnets and the external driver magnets is modified such that the coupling is neither strictly axial nor strictly radial. Also disclosed are “receiver-less” retainer configurations whereby the single-use container need not have a rigid base that defines a cup or post to engage of rotatable agitator.

Abstract: Disclosed herein are embodiments of a valve assembly for preventing dead leg spaces in a container or tubing, the embodiments including a three-way valve system for controlling back-pressure in a fluid generating device, such as a single-use high pressure bioreactor. Also disclosed is a pressurized reactor system for bioprocessing, comprising a single-use container including a flexible wall or a semi-rigid wall.

Abstract: Disclosed is a heat exchange module for use in a chemical, pharmaceutical or biological reactor system, the module configured to be disposed in the reactor system having a flexible single use container, and including at least one thermally conductive surface adapted to contact the flexible single use container to facilitate heat transfer, and a fluid circulation path through which a heat exchange fluid can be circulated.

Abstract: Disclosed herein is a system and method for condensing moisture in a moist gas stream entering a bioreactor or leaving a bioreactor, forming a dry gas stream for entering or leaving the bioreactor.

Abstract: Disclosed herein are embodiments of a valve assembly for preventing dead leg spaces in a container or tubing, the embodiments including a three-way valve system for controlling back-pressure in a fluid generating device, such as a single-use high pressure bioreactor. Also disclosed is a pressurized reactor system for bioprocessing, comprising a single-use container including a flexible wall or a semi-rigid wall.

Abstract: A heat exchange module for use in a chemical, pharmaceutical or biological reactor system includes a generally hollow body having an interior space for receiving a replaceable or single use reactant container, and at least one thermally conductive surface adapted to contact the replaceable reactant container to facilitate heat transfer, a fluid circulation path formed within the body between an outer wall of the body and an inner wall of the body through which a heat exchange fluid can be circulated, and at least one baffle protruding from the inner wall of the body into the interior space.

Abstract: A heat exchange module for use in a chemical, pharmaceutical or biological reactor system can include a body configured to be disposed in the reactor system having an inner replaceable reactant container is disclosed. The body can further include at least one thermally conductive surface adapted to contact the inner replaceable reactant container to facilitate heat transfer. Furthermore, the heat exchange module can include a heat exchanger disposed within the module body and can include a fluid circulation path through which a heat exchange fluid can be circulated.

Abstract: Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. In certain embodiments, such vessels and unit operations are directed to continuous perfusion reactor or bioreactor systems and may include one or more disposable components. For instance, in one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells which produce one or more products. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle.

Abstract: Disclosed is a heat exchange module for use in a chemical, pharmaceutical or biological reactor system, the module configured to be disposed in the reactor system having a flexible single use container, and including at least one thermally conductive surface adapted to contact the flexible single use container to facilitate heat transfer, and a fluid circulation path through which a heat exchange fluid can be circulated.

Abstract: A single-use, single or multiple tissue, organ, and graft bioreactor and environmental control system is designed to replicate the necessary conditions for growth of tissues, organs, or grafts, while addressing problems in scaling up the tissue growth; adaptation to a single-use or disposable format; and operation as a stand-alone unit that provides full environmental control of cell culture conditions.

Abstract: Systems and methods for containing and manipulating liquids, including vessels and unit operations or components of cell culture, cell containment, bioreactor, and/or pharmaceutical manufacturing systems, are provided. In certain embodiments, such vessels and unit operations are directed to continuous perfusion reactor or bioreactor systems and may include one or more disposable components. For instance, in one aspect, a system includes an apparatus in the form of a bioreactor for harvesting cells which produce one or more products. The apparatus may include a disposable, collapsible bag adapted for containing a liquid, the collapsible bag in fluid communication with a liquid-solids (e.g., cell) separation device. For example, an outlet of the collapsible bag may be connected to an inlet of the separation device, and an outlet of the separation device may be connected to an inlet of the collapsible bag for recycle.

Abstract: Disclosed is a sensor and housing assembly for a single-use bioreactor system, including a device for operatively associating a sensor with a flexible wall, the device comprising an internal housing portion that is removable and variably positionable on an internal surface of the flexible wall, the internal housing portion comprising a chemical detector sensor, which may be an optical chemical detector sensor.

Abstract: Systems for containing and manipulating fluids including systems and methods involving supported collapsible bags that may be used as reactors for performing chemical, biochemical and/or biological reactions contained therein are provided. Generally, a series of improvements and features for fluid containment systems such as gas delivery configurations, foam control systems and bag molding methods and articles for supported collapsible bag vessels and bioreactors are provided. For instance, in one aspect, fluids contained in a vessel can be sparged, e.g., such that a fluid is directed into a container of the vessel, and in some cases, the sparging can be controlled by rapidly activating or altering the degree of sparging as needed. Multiple spargers may be used in some cases. In another aspect, the vessel includes a seamless collapsible bag. In some cases, the collapsible bag may be injected, blown, or spin cast molded.